A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures

Purpose

The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.

Conditions

  • Pediatric Surgical Procedures
  • Adult Surgical Procedures
  • Adult Gynecological Procedures
  • Adult Urological Procedures
  • Adult Thoracic Procedures

Eligibility

Eligible Ages
Under 110 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Pediatric participants - Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU - Less than 18 years of age at the time of procedure - Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants - Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU - Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU

Exclusion Criteria

Preoperative - Physical or psychological condition which would impair study participation - Participants of childbearing potential who are pregnant - Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative - HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears) This prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 700 Shears instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery.
  • Device: HARMONIC 700 Shears
    There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use.

Recruiting Locations

Riley Hospital for Children at Indiana University Health
Indianapolis 4259418, Indiana 4921868 46202

Icahn School of Medicine at Mt. Sinai
New York 5128581, New York 5128638 10029

More Details

Status
Recruiting
Sponsor
Ethicon Endo-Surgery

Study Contact

Study Contact
904-443-1474
kcanava2@its.jnj.com